RGUHS M.Pharm 2nd Year Last 10 Years 2011-2021 Question Papers || Rajiv Gandhi University of Health Sciences
Second Semester M. Pharm Examination
[Time: 3 Hours] [Max. Marks: 75]
Scale up and Technology Transfer
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Q.P. CODE: 5142
Your answers should be specific to the questions asked.
Draw neat, labeled diagrams wherever necessary.
LONG ESSAY (Answer any Three) 3 X 10 = 30 Marks
- Draw the flow chart of technology transfer in pharmaceutical industry and discuss in detail scale up process for liquid orals.
- Explain cleaning validation. Discuss factors influencing cleaning validation.
- Discuss installation, operational and performance qualifications for rapid mixer granulator.
- List out environmental pollution and discuss control over environmental pollution.
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SHORT ESSAY (Answer any Nine) 9 X 5 = 45 Marks
- Write a note on common problems encountered during technology transfer.
- Explain development phase of technology transfer from R & D to production for capsules.
- What are the responsibilities of validation team during validation process?
- Give the objectives and importance of validation master plan.
- Discuss the operational and performance qualifications for cone blender.
- Write the installation and operational qualifications for autoclave.
- Explain the process validation for tablet coating.
- Explain the process validation for liquid filling and sealing.
- Describe the general methods of preventing hazards in an industry.
- Define the term safety and discuss the elements of safety programme.
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